Medicament delivery and simulation system with a removable disposable container for medicament and a rotatable actuation component

ABSTRACT

In one embodiment of the invention, a container for storing a medicament prior to use is provided. The container includes a first housing for containing a medicament, a second housing, wherein the first housing is movable relative to the second housing, and an injection member associated with a lower portion of the first housing, wherein when the first housing moves relative to the second housing in a first direction to deliver the medicament, the injection member extends from the second housing traversing a first contaminant barrier disposed at a lower portion of the second housing. The first housing moves relative to the second housing in a second direction wherein the injection member is retracted into the second housing to prevent an unintentional contact with the injection member. In a further embodiment, an actuation mechanism for actuation of an injection includes a rotatable member.

CROSS REFERENCE RELATED APPLICATIONS

This application claims priority to Provisional Application No.61/788,033 filed on Mar. 15, 2013.

BACKGROUND

Manual disposable syringe based devices have existed since themid-1800's. These devices were designed for a single purpose ofperforming a subcutaneous injection through a hollow-bore needle affixedto the syringe device. Syringes are simple mechanical systems with nocapability of refined fluid dynamics or ability to integrate advanceddigital capabilities.

Auto-injection or “pen” devices have recently become increasinglypopular for single dose or multi dose, at home self-administration.These auto-injection devices are primarily designed to accomplish twobasic objectives: convenience and automation of drug delivery in anoutpatient setting. These are typically mechanically spring-loadeddevices that advance a plunger or rubber stopper to transfer medicationvia hollow-bore needle to a patient's tissues.

Auto-injection devices lack the ability to regulate whether themedication is actually delivered to the patient or whether it isdelivered to a correct location. Most auto-injection devices fail tointegrate advanced digital capabilities. A significant limitation is theinability of auto-injection devices to collect and transfer digitalinformation from the device to other sources.

Injectable medications are required for a number of varying illnessesand diseases. A number of injectable medications require self-injectionby a patient. Self-injection of a medicament using a device having aneedle carries with it a certain stigma. Oftentimes patients are wearyof injecting themselves for fear or anxiety related to failing toreceive a complete dose of the medication, pain associated withinjecting oneself with the needle, accidentally sticking oneself withthe needle, and difficulties in adequately grasping the dosing mechanismto inject oneself, among other concerns.

Auto-injection devices are routinely used to provide a means forself-injecting certain medications. The size and operation of theseauto-injection devices can often be daunting to a patient, whether theyare injecting themselves for the first or they have injected themselvesbefore. These fears and anxieties associated with the currentlyavailable self-injection devices, particularly the auto-injectiondevices, may result in the administration of an incomplete dose of amedicament, failure to administer any portion of the dose of amedicament, or accidentally sticking oneself with the needle of thedevice, which in some instances could lead to unwanted transmission ofdiseases if the needle is contaminated.

In some instances, after an auto-injection is complete, the contaminatedneedle is retracted within the auto-injection device or covered over bya needle guard or sheath and the entire auto-injection device isdisposed of. Therefore, most auto-injectors currently available aresingle use auto-injectors. These single use auto-injectors are costlyand economically wasteful. Alternatively, there are injection deviceswhich require a user to re-cap a needle after the injection is completesuch that the disposable needle can be removed and discarded. Theseinjection devices carry with them the risk of unwanted sticking ofoneself during re-capping of the needle.

An additional concern exists with regard to injection devices, and inparticular with regard to auto-injectors, where users with little or nomedical knowledge or experience are injecting themselves or injectingothers using these devices. Performing a medical treatment or test ononeself or others carries with it certain risks and often creates alevel of anxiety for the user performing the treatment or test. It hasproven beneficial in the medical field to practice various medicaltechniques including drug delivery, specifically where it relates toinjections and other invasive drug delivery means prior to deliveringthe medications to a patient in need, and particularly in the case ofself-administration of medicaments. Training devices are helpful inreducing anxiety associated with self administering medical treatment,as well as increasing efficiency and accuracy in providing the treatmentto patients. Medical devices can be intimidating to use; the fearassociated with giving oneself an injection, for example, can betraumatic. This fear is increased in persons with little or noexperience in self-administration of medications. Consequently, devicesto assist in training individuals to inject themselves or otherwiseself-administer medication are beneficial in decreasing or preventingthe anxiety associated with medicament delivery.

Therefore, there exists a need for an injection device which may besafely and efficiently used by patients without medical experience inpreparing and self-injecting medications. Furthermore, a device whichclosely resembles a medicament delivery device that can be used tosimulate an injection for training purposes would be highly beneficial.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description briefly stated above will be rendered byreference to specific embodiments thereof that are illustrated in theappended drawings. Understanding that these drawings depict only typicalembodiments and are not therefore to be considered to be limiting of itsscope, the embodiments will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1A provides a cross-sectional view of an embodiment of a container.

FIG. 1B provides an exploded view of the embodiment of the container inFIG. 1A.

FIGS. 2A-2D′ illustrate an embodiment of a medicament delivery orinjection simulation system and illustrate steps of the use of theembodiment of the system.

SUMMARY

In one embodiment, a container for storing a medicament prior to use isprovided. The container includes a first housing for containing amedicament, a second housing, wherein the first housing may be movablerelative to the second housing, and an injection member associated witha lower portion of the first housing. The container further includeswhen the first housing moves relative to the second housing in a firstdirection to deliver the medicament, the injection member extends fromthe second housing traversing a first contaminant barrier disposed at alower portion of the second housing, and the first housing movesrelative to the second housing in a second direction the injectionmember may be retracted into the second housing to prevent anunintentional contact with the injection member.

In another embodiment, a medicament delivery or injection simulationsystem is provided. The medicament delivery or injection simulationsystem includes a container, and the container includes a first housingand a second housing, wherein the first housing may be movable relativeto the second housing, and an injection member or an injectionsimulation member associated with a lower portion of the first housing.When the first housing moves relative to the second housing in a firstdirection, the injection member or injection simulation member extendsfrom the second housing traversing a first contaminant barrier disposedat a lower portion of the second housing. When the first housing movesrelative to the second housing in a second direction, the injectionmember or injection simulation member may be retracted into the secondhousing to prevent an unintentional contact with the injection member orinjection simulation member. The medicament delivery or injectionsimulation system further includes an actuation mechanism associatedwith the container, wherein actuation mechanism drives the movement ofthe first housing and/or the second housing. In some embodiments, theactuation mechanism may include a motor.

In yet another embodiment, a container for storing a medicament prior touse is provided. The container includes a first housing for containing amedicament, a second housing, wherein the first housing is movablerelative to the second housing, and an injection member associated witha lower portion of the first housing. The container further includes aplunger associated with the first housing, the plunger being movablerelative to the first housing, wherein when the first housing movesrelative to the second housing in a first direction to deliver themedicament, the injection member extends from the second housingtraversing a first contaminant barrier disposed at a lower portion ofthe second housing, and wherein when the plunger moves relative to thefirst housing in a first direction, medicament is delivered through theinjection member, and when the first housing moves relative to thesecond housing in a second direction the injection member is retractedinto the second housing to prevent an unintentional contact with theinjection member.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles andoperation of the invention, reference will now be made to theembodiments illustrated in the drawings and specific language will beused to describe the same. It will nevertheless be understood that nolimitation of the scope of the invention is thereby intended, suchalterations and further modifications in the illustrated device, andsuch further applications of the principles of the invention asillustrated therein being contemplated as would normally occur to thoseskilled in the art to which the invention pertains.

It is to be noted that the terms “first,” “second,” and the like as usedherein do not denote any order, quantity, or importance, but rather areused to distinguish one element from another. The terms “a” and “an” donot denote a limitation of quantity, but rather denote the presence ofat least one of the referenced item. The modifier “about” used inconnection with a quantity is inclusive of the stated value and has themeaning dictated by the context. It is to be noted that all rangesdisclosed within this specification are inclusive and are independentlycombinable.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. As used herein, thesingular forms “a,” “an,” and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise.Furthermore, to the extent that the terms “including,” “includes,”“having,” “has,” “with,” or variants thereof are used in either thedetailed description and/or the claims, such terms are intended to beinclusive in a manner similar to the term “comprising.” Moreover, unlessspecifically stated, any use of the terms first, second, etc., does notdenote any order or importance, but rather the terms first, second,etc., are used to distinguish one element from another.

Notwithstanding that the numerical ranges and parameters setting forththe broad scope are approximations, the numerical values set forth inspecific non-limiting examples are reported as precisely as possible.Any numerical value, however, inherently contains certain errorsnecessarily resulting from the standard deviation found in theirrespective testing measurements. Moreover, all ranges disclosed hereinare to be understood to encompass any and all sub-ranges subsumedtherein. As a non-limiting example, a range of “less than 10” caninclude any and all sub-ranges between (and including) the minimum valueof zero and the maximum value of 10, that is, any and all sub-rangeshaving a minimum value of equal to or greater than zero and a maximumvalue of equal to or less than 10, e.g., 1 to 7.

DEFINITIONS

The term “associated” or “association”, as used herein, includes but isnot limited to direct and indirect attachment, adjacent to, in contactwith, partially or fully attached to, and/or in close proximitytherewith. The term “in conjunction with” as used herein includes but isnot limited to synchronously or near synchronous timing, the phrase mayalso include the timing of outputs, where one output directly followsanother output. The term “value” as used herein, may refer to a specificvalue or a range of values.

The inventors have discovered many areas in which prior art injectiondevices and syringes are lacking, particularly in regard to certainsafety and convenience features. While some safety syringes are providedwith a retraction-type mechanism, such that after using the syringe theneedle can be retracted into some kind of housing of the syringe;however, the syringe still requires removing a protective cap from theneedle prior to injection. These prior art syringes presentopportunities for unwanted sticking of oneself with the needle. Theseprior art syringes also present opportunities for contamination of theneedle before it is injected into the skin of a user. Another area ofthe prior art that is lacking in efficiency includes where an autoinjector is used for an injection, and the housing may be disposed ofafter a single use. It is not economically efficient to dispose of anauto injector after a single injection. Therefore, the inventors hereinhave identified a medicament containing container which solves many ofthese issues identified in the prior art.

The subject invention includes, in one embodiment, a medicamentcontaining container which comprises a needle, wherein the medicamentcontaining container may be configured to be received within aninjection device. The medicament containing container comprises a needleand a safety guard and/or packaging such that the needle may beprotected and kept sterile until the container is inserted into theinjection device in an embodiment. Upon insertion of the container intothe injection device, the safety guard is removed and/or the packagingis opened such that the needle is positioned within the injection devicefor use upon injection by the user.

Following injection of the medicament contained within the medicamentcontaining container, the needle automatically retracts into themedicament containing container such that a user cannot access theneedle, in an embodiment. Thereafter, the empty container comprising theneedle can be removed or extended from the injection device anddisposed, leaving the injection device ready and able to receive anothermedicament containing container for the next injection, one embodiment.In one embodiment, placing the container into the injection deviceautomatically opens the sterile packaging surrounding the needle portionand/or displaces the safety guard in preparation of the needle forinjection. Therefore, the needle and the medicament maintain sterilityuntil the container is inserted into the injection device prior toinjection into the patient.

In one particular embodiment, a seal may be provided over the needle endof the container to protect the sterility of the container and theneedle, prior to its use. During an injection, the needle punctures theseal and traverses the sealed container portion as it exits the proximalend of the injection device into the injection site of the patient.

Following use of the needle for injection, the needle may be retractedinto the container such that the container can be safely removed from areusable housing for disposal. The retraction of the needle into thecontainer prevents unwanted and accidental needle sticks by the patientduring the manipulation of the container between its removal from thehousing and disposal in a sharps container. Furthermore, in order tocomply with regulations regarding needle safety and proper disposal ofneedles, the retraction of the needle prevents it from being a danger toothers, as the needle cannot be accessed once it is retracted within thecontainer.

In one embodiment, the container may be a training (or injectionsimulation) container, in which an injection simulation member isprovided in place of the needle for injection. The training containermay be placed within the injection device to assist a user in learningto correctly use the device. The training container may be labeled as atraining container, and may contain unique identification information ona portion of the container to identify it as a non-medicament containingcontainer or training container. When the training container is placedwithin a housing for use, as will be described in greater detail below,the housing may include an information identification reader whichidentifies the container as a training container. The housing may be areusable housing, in one embodiment.

In one embodiment, a medicament delivery system is provided. Themedicament delivery system includes reusable housing, the reusablehousing including an actuation mechanism and a receptacle for receivinga container. The actuation mechanism is provided for interacting withthe container. The container may be provided for storing a medicamentprior to use, the container includes a first housing for containing amedicament, a second housing, wherein the first housing may be movablerelative to the second housing, and an injection member associated witha lower portion of the first housing. The container further includeswherein the actuation mechanism interacts with the container such thatthe first housing moves relative to the second housing in a firstdirection the injection member may be extended from the second housing,traversing a first contaminant barrier, the plunger component movesrelative to the first housing in a first direction to expel themedicament through the injection member, and the first housing movesrelative to the second housing in a second direction such that theinjection member may be retracted into the second housing to prevent anunintentional contact with the injection member. The container can beremoved from the reusable housing post use and disposed of.

In a further embodiment, the actuation mechanism depresses the plungercomponent to deliver the medicament thorough the injection member afterthe injection member traverses the first contaminant barrier.

In a further embodiment the injection member traverses the firstcontaminant barrier and the plunger component may be depressed so as todeliver the medicament through the injection member. In a particularembodiment, the first contaminant barrier may be a membrane.

In still a further embodiment, a spring may be disposed between thefirst housing and the second housing such that when the first housingmoves relative to the second housing in a first direction, the spring isbiased, and when the medicament may be delivered from the injectionmember, the spring may be released and the injection member may beretracted into the second housing. In yet a further embodiment, themedicament delivery system further includes a second contaminant barrierbetween an upper portion of the second housing and a lower portion ofthe first housing to prevent contaminants from entering the secondhousing. In a further embodiment, a third contaminant barrier may bedisposed between the plunger component and the first housing to preventcontaminants from entering the first housing and/or the medicament.Non-limiting examples of contaminant barriers include but are notlimited to membranous materials or membranes. O-ring type membranes orcontaminant barriers may be used in the second and third contaminantbarrier positions, in non-limiting examples. A membrane may be used as acontaminant barrier in the first contaminant barrier position, in onenon-limiting example.

In a further embodiment, the medicament delivery system is providedwherein the first housing includes a projection member that interactswith the actuation mechanism to cause the first housing to move relativeto the second housing such that the injection member traverses the firstcontaminant barrier when the actuation mechanism is activated.

In another embodiment, the medicament delivery system is providedwherein when the actuation mechanism is activated, the actuationmechanism interacts with a portion of the first housing to move thefirst housing in a first direction relative to the second housing suchthat the spring is biased and the injection member traverses the firstcontaminant barrier.

The actuation mechanism can be activated in various ways. Depressing anactuation mechanism by turning a switch or by contact with a portion ofthe medicament delivery system, or by inserting the container into thehousing, is one non-limiting example of activating an actuationmechanism, another non-limiting example of an actuation mechanismincludes a motor.

In another embodiment of the medicament delivery system, the actuationmechanism may be a rotatable member. The rotatable member includes afirst threaded portion and a second threaded portion, in one embodiment,the second threaded portion provided to interact with the projectionmember such that when the actuation mechanism may be rotated in a firstdirection, the second threaded portion moves the projection member in afirst direction relative to the second housing, such that the spring isbiased and the injection member may be extended through the firstcontaminant barrier. In a further embodiment, the first threaded portionof the actuation mechanism may be provided to interact with the upperportion of the plunger component such that when the actuation mechanismmay be rotated in a first direction, the first threaded portion movesthe plunger component relative to the first housing in a first directionto expel the medicament through the injection member. In anotherembodiment, the second threaded portion contacts the projection memberto move the first housing in a first direction relative to the secondhousing before the first threaded portion of the rotatable membercontacts the upper portion of the plunger component to move the plungercomponent in a first direction relative to the first housing to dispelor deliver the medicament through the injection member.

In a further embodiment, the second threaded portion of the rotatablemember includes an opening through which the projection member may bereleased, such that the first housing moves in a second directionrelative to the second housing, to retract the injection member into thesecond housing. The rotatable member may be rotated by a motor or atorsion spring, or by hand in some embodiments, or a combinationthereof, or any other means of rotation of the rotatable member known tothose of skill in the art.

In an embodiment, the container comprises a unique identificationinformation or a container information component including a uniqueidentification information of the medicament contained within, wherebythe identification information can be read by an identification readeror container information component reader. The rotatable member mayinclude an identification reader, the reusable housing may include anidentification reader and/or the actuation mechanism may include anidentification reader, in an embodiment. The container informationcomponent and container information component reader may interact withone another such that information identified by the reader can beprovided to the user. The information may be provided to a user on adisplay, or another visual communication device, or audibly provided tothe user. The information may further be provided with a smell or avibration, or by any other method of communication known in the art. Theinformation may be provided, in a non-limiting example, by way of a barcode, or by a specific shape on the container which can be read by thereader to identify specific information about the medicament containedwithin the container. Such information may include the name and strengthof the drug, the expiration date, dose, manufacturer's name, batchnumber, proper handling instructions (e.g., temperature storageconditions) among other information.

The container information component may further be designed to identifyand record particular information regarding the container and themedicament stored within, such as the temperature at which the containerhas been maintained from the manufacturer through the delivery processin a non-limiting example. A log may be recorded by the system of thevarying temperatures of the container and the medication by a module ofthe container so that a user can identify if the container has beenmaintained at a proper temperature prior to use of the medicament. Forthis and other purposes, the container may include a power source suchas a battery, in a non-limiting example. Therefore, medicaments whichhave not been maintained at the proper storage/handling temperature canbe discarded. In instances where the container information componentreader identifies information on the container information component,such as, information that the container may be housing an expiredmedication, the safety mechanism will prevent an activation of theactuation device, and therefore prevent injection of the expiredmedication into the user, in a non-limiting example.

In another embodiment, the medicament delivery system is providedwherein the actuation mechanism interacts with the plunger componentsuch that the first housing to moves in a first direction relative tothe second housing such that the injection member traverses the firstcontaminant barrier when the actuation mechanism is activated. In afurther embodiment, the actuation mechanism may be a rotatable member,in one non-limiting example the rotatable member is an index cam. Therotatable member includes a first threaded portion, the first threadedportion provided to interact with an upper portion of the plungercomponent such that when the actuation mechanism is rotated in a firstdirection, the first threaded portion moves the first housing in a firstdirection relative to the second housing such that the spring is biasedand the injection member may be extended through the first contaminantbarrier.

In a further embodiment, thereafter, the actuation mechanism interactswith the plunger component such that the plunger component moves in afirst direction relative to the first housing so as to expel themedicament through the injection member, and the first housing movesrelative to the second housing in a second direction such that theinjection member may be retracted into the second housing to prevent anunintentional contact with the injection member. When the actuationmechanism is activated, the first housing moves in a first directionrelative to the second housing to extend the injection member throughthe first contaminant barrier before the plunger component moves in afirst direction relative to the first housing to expel the medicamentthrough the injection member and to a subject, in one embodiment. Thiscan occur with only a first threaded portion which interacts with theplunger component.

The system operates in such a manner due in part at least to adifference in resistance between the movement of the first housingrelative to the second housing and the extension of the injection memberthrough the first contaminant barrier and the resistance between themovement of the plunger component relative to the first housing todispel the medicament through the injection member. The first actionwill occur before the second as the system will take the path of leastresistance. Thus, there is less resistance associated with the extensionof the injection member through the first contaminant barrier and intothe subject (i.e., movement of the first housing in a first directionrelative to the second housing) than there is associated with themovement of the plunger component relative to the first housing todispel the medicament through the injection member and into the subject.

In still a further embodiment, the first threaded portion includes anopening through which the projection member may be released, whereby thespring may be released, such that the first housing moves in a seconddirection relative to the second housing, and the injection memberretracts into the second housing.

The rotatable member can be rotated by a torsion spring or a motor, or acombination thereof. Those skilled in the art will appreciate that otherforces and devices may be used to rotate the rotatable member in such amanner to depress the components of the device as described herein.

In another embodiment, a container for storing a medicament prior to useis provided. The container includes a first housing for containing amedicament, a second housing, wherein the first housing may be movablerelative to the second housing, and an injection member associated witha lower portion of the first housing. The container further includeswherein when the first housing moves relative to the second housing in afirst direction to deliver the medicament, the injection member extendsfrom the second housing traversing a first contaminant barrier disposedat a lower portion of the second housing, and the first housing movesrelative to the second housing in a second direction, the injectionmember is retracted into the second housing to prevent an unintentionalcontact with the injection member. In a further embodiment, a stoppermay be associated with the first housing. The stopper may be movablerelative to the first housing, whereby the medicament is deliveredthrough the injection member upon movement of the first housing relativeto the second housing in a first direction followed by movement of thestopper relative to the first housing in a first direction.

The container may be manually actuated by pressing down on the stopper,in one embodiment. Alternatively, in a non-limiting example, thecontainer may be actuated with an actuation mechanism, wherein theactuation mechanism may be rotatable as an index cam, which may beactivated manually via a torsion spring or by motor, gas, or compressedair, among other possible activation means known to those of skill inthe art. Alternatively, the container may, itself, be actuated via amotor, gas or compressed air. Any other means of activation or actuationof the container to deliver medicament that are known to those of skillin the art are included herein.

In a further embodiment, the injection member traverses the firstcontaminant barrier and the stopper may be depressed so as to deliverthe medicament through the injection member. In one embodiment, thefirst contaminant barrier may be a membrane. In another embodiment, thefirst contaminant barrier may include any material or device known tothose of skill in the art to prevent unwanted contaminants from enteringthe device.

In a further embodiment, a spring may be disposed between the firsthousing and the second housing wherein when the first housing movesrelative to the second housing in a first direction, the spring isbiased, and after the medicament is delivered from the injection member,the spring may be released, and the injection member may be retractedinto the second housing. This feature is beneficial, in one instance, toprevent unwanted sticking of oneself with the used injection member.After use of the device or container, the injection member is protectedto allow disposal without accidental sticking of oneself with theinjection member and prevention of potential contamination of oneselfthrough contact with the injection member.

In a further embodiment, the container further includes a secondcontaminant barrier between the upper portion of the second housing andthe lower portion of the first housing to prevent contaminants fromentering the second housing.

In another embodiment, the container further includes a thirdcontaminant barrier between the first and second housing to preventcontaminants from entering the first housing and/or from being incontact with the medicament.

In a further embodiment, a medicament delivery and simulation system isprovided, the system including a container, the container including afirst housing, a second housing, wherein the first housing may bemovable relative to the second housing and an injection member or aninjection simulation member may be associated with a lower portion ofthe first housing. When the first housing moves relative to the secondhousing in a first direction, the injection member or injectionsimulation member extends from the second housing traversing a firstcontaminant barrier disposed at a lower portion of the second housing,and when the first housing moves relative to the second housing in asecond direction the injection member or injection simulation member maybe retracted into the second housing to prevent an unintentional contactwith the injection member or injection simulation member. The medicamentdelivery and simulation system further includes an actuation mechanismin association with the container, wherein the actuation mechanismdrives the movement of the first housing and/or the second housing. In afurther embodiment, the actuation member comprises a motor. Theactuation mechanism may include a motor, an index cam, a plungercomponent, or any manually or electrically activated actuationmechanism, in non-limiting examples. Other actuation mechanisms known tothose of skill in the art are contemplated herein.

In a further embodiment, the medicament delivery and simulation systemis provided wherein the first contaminant barrier is a membrane. In oneembodiment, the container includes a medicament. In still a furtherembodiment, a stopper may be associated with the first housing, thestopper being movable relative to the first housing, whereby themedicament may be delivered through the injection member upon movementof the first housing relative to the second housing in a first directionfollowed by movement of the stopper relative to the first housing in afirst direction.

In yet a further embodiment, the actuation member may be a motor whichdrives the movement of the stopper. In yet another embodiment of themedicament delivery and simulation system, the system further comprisesa second contaminant barrier between an upper portion of the secondhousing and the lower portion of the first housing to preventcontaminants from entering the second housing. In still a furtherembodiment, a third contaminant barrier may be disposed between thestopper and the first housing to prevent contaminants from entering thefirst housing and/or the medicament, alternatively the stopper includesa third contaminant barrier or the stopper may be associated with thethird contaminant barrier. In another embodiment, a shaft may beconnected to the stopper.

In a further embodiment, the system includes a reusable housing having areceptacle for receiving the container. In still a further embodiment,the actuation mechanism is in the reusable housing.

In another embodiment, a medicament delivery system is provided, whereinthe system may be configured to provide stepwise instructions for usingthe system to a user in a particular sequence. The system includes areusable housing, the housing comprising an actuation mechanism and areceptacle for receiving a container. The actuation mechanism is forinteracting with the container, the reusable housing including a controlinterface, the control interface including at least one responsivemember reactive to a user input. The housing includes a container forstoring a medicament prior to use, the container including a firsthousing for containing a medicament, a second housing, wherein the firsthousing is movable relative to the second housing, a plunger componentassociated with the first housing, and an injection member associatedwith a lower portion of the first housing.

The system further includes a signal output component associated withthe reusable housing component and circuitry associated with thereusable housing component configured to control a provision of thestepwise instructions to the user in the particular sequence. In onenon-limiting example, the stepwise instructions are audibly provided tothe user via the signal output component. The instructions can be arecording of any language providing verbal instructions. Alternatively,the instructions may be given with a series of sounds or beeps or otheraudible notifications to a user. In other embodiments, the instructionsmay be provided by one or a series of vibrations of the system or ascent or taste or temperature change of the system or the housing.Instructions may alternatively be provided visually, wherein a textualinstruction may be provided or a pictorial or video-type instruction.Various lights may also be used to signal the stepwise instructions to auser via a series of lighted portions on the housing signaling the stepsin which the system may be used, or any other lighted signaling manneras known by those of ordinary skill in the art. Any of these sounds,visual guides, vibrations, tastes or smells may be provided via thesignal output component, in one embodiment.

Upon activation of the actuation mechanism, the actuation mechanisminteracts with the container such that the first housing moves relativeto the second housing in a first direction, the injection member may beextended from the second housing, traversing a first contaminantbarrier, the plunger component moves relative to the first housing in afirst direction to expel the medicament through the injection member,and the first housing moves relative to the second housing in a seconddirection such that the injection member may be retracted into thesecond housing to prevent an unintentional contact with the injectionmember. In one particular embodiment, a spring may be disposed betweenthe first and second housings such that when the first housing movesrelative to the second housing in a first direction, the spring isbiased, and after the medicament is delivered from the injection member,the spring may be released and the injection member may be retractedinto the second housing.

In a further embodiment, the first housing comprises at least aprojection member that interacts with the actuation mechanism to causethe first housing to move relative to the second housing such that theinjection member traverses the first contaminant barrier when theactuation mechanism is activated.

In still a further embodiment, when the actuation mechanism isactivated, the actuation mechanism interacts with a portion of the firsthousing to move the first housing in a first direction relative to thesecond housing such that the injection member traverses the firstcontaminant barrier.

In yet a further embodiment, the actuation mechanism may be a rotatablemember, the rotatable member may include a first threaded portion and asecond threaded portion, the second threaded portion provided tointeract with the projection member such that when the actuationmechanism is rotated in a first direction, the second threaded portionmoves the projection member in a first direction relative to the secondhousing such that the spring is biased and the injection member isextended through the first contaminant barrier. One skilled in the artin view of the teachings herein would understand that the first threadedportion could associate with a top portion or other portion of the firsthousing to move the first housing in a first direction relative to thesecond housing.

In another embodiment, the first threaded portion of the actuationmechanism is provided to interact with an upper portion of the plungercomponent such that when the actuation mechanism is rotated in a firstdirection, the first threaded portion moves the plunger componentrelative to the first housing in a first direction to expel themedicament through the injection member.

In yet another embodiment, the second threaded portion comprises anopening through which the projection member is released, whereby thespring is released, such that the first housing moves in a seconddirection relative to the second housing, and the injection memberretracts into the second housing.

In another embodiment, the system may include a locking mechanismdisposed adjacent to the first and/or second housing so as to preventmovement of the plunger component in a first direction relative to thefirst housing and the first housing in a first direction relative to thesecond housing when the locking mechanism is activated. In a furtherembodiment, insertion of the container into the receptacle of thereusable housing inactivates the locking mechanism. In anotherembodiment, removal of the container from the receptacle of the reusablehousing activates the locking mechanism disposed adjacent to the secondhousing so as to prevent movement of the first housing in a firstdirection relative to the second housing and/or the second housing in asecond direction relative to the first housing. The locking mechanismcan be arranged in the system and device such that pre-delivery of themedicament or pre-simulation, the first and second housings cannot moverelative to one another, and plunger component cannot move relative tofirst housing and post-delivery or post-simulation, the first and secondhousings cannot move relative to one another, but the plunger componentmay be freely movable, in one embodiment.

In still a further embodiment, the container can be removed from thereusable housing post use. In these embodiments, the housing may bereusable and the container may be removed after use and disposed. In analternative embodiment, the system can be embodied as a single usesystem, wherein the entire housing is disposed after use. In certainsingle-use embodiments, the container may not be removed from thehousing before disposal of the housing.

In a further embodiment, a medicament delivery system configured toprovide stepwise instructions for using the system to a user in aparticular sequence is provided. The system includes a housingcomponent, the housing component comprising an actuation mechanism, theactuation mechanism for interacting with a container. The container forstoring a medicament prior to use includes a first housing forcontaining a medicament, a second housing, wherein the first housing maybe movable relative to the second housing, a plunger componentassociated with the first housing, and an injection member associatedwith a lower portion of the first housing. The housing component mayinclude a control interface which may include at least one responsivemember reactive to a user input. The housing component may furtherinclude a signal output component associated therewith, and circuitryassociated therewith, the circuitry configured to control a provision ofthe stepwise instructions to the user in the particular sequence. Uponactivation of the system, the actuation mechanism interacts with thecontainer such that the first housing moves relative to the secondhousing in a first direction the injection member may be extended fromthe second housing, traversing a first contaminant barrier, the plungercomponent moves relative to the first housing in a first direction toexpel the medicament through the injection member, and the first housingmoves relative to the second housing in a second direction such that theinjection member may be retracted into the second housing to prevent anunintentional contact with the injection member.

In one particular embodiment, a spring may be disposed between the firsthousing and the second housing such that when the first housing movesrelative to the second housing in a first direction, the spring isbiased, and when the medicament is delivered from the injection member,the spring is released and the injection member may be retracted intothe second housing.

In a further embodiment, the first housing comprises at least aprojection member that interacts with the actuation mechanism to causethe first housing to move relative to the second housing such that theinjection member traverses the first contaminant barrier when theactuation mechanism is activated.

In still a further embodiment, when the actuation mechanism isactivated, the actuation mechanism interacts with a portion of the firsthousing to move the first housing in a first direction relative to thesecond housing such that the injection member traverses the firstcontaminant barrier.

In yet a further embodiment, the actuation mechanism may be a rotatablemember, the rotatable member comprising a first threaded portion and asecond threaded portion, the second threaded portion provided tointeract with the projection member such that when the actuationmechanism is rotated in a first direction, the second threaded portionmoves the projection member in a first direction relative to the secondhousing such that the spring may be biased and the injection member maybe extended through the first contaminant barrier.

In another embodiment, the first threaded portion of the actuationmechanism may be provided to interact with an upper portion of theplunger component such that when the actuation mechanism is rotated in afirst direction, the first threaded portion moves the plunger componentrelative to the first housing in a first direction to expel themedicament through the injection member.

In yet another embodiment, the second threaded portion comprises anopening through which the projection member is released, whereby thespring may be released, such that the first housing moves in a seconddirection relative to the second housing, and the injection memberretracts into the second housing.

Turning to the Figures, FIG. 1A illustrates a cross-sectional view andFIG. 1B provides an exploded view of an embodiment of a container 11,the container 11 comprising a first housing 10, a second housing 12, aninjection member 16 and a spring 30 disposed between a lower portion 18of the first housing and a lower portion 22 of the second housing. Thecontainer 11 further includes a first contaminant barrier 26 disposed ata lower portion 22 of the second housing. A plunger component 28 isprovided associated with the first housing 10. The plunger component 28may include a stopper 28B and a shaft 28A in an embodiment, as shown inFIGS. 1A-1B. A third contaminant barrier 36 is disposed between theplunger component 28 and the first housing 10 and prevents contaminantsfrom entering the first housing 10 contacting a medicament 14 containedwithin the first housing 10. A second contaminant barrier 34 between thesecond housing 12 and the first housing 10 prevents contaminants fromentering the second housing and contacting an inner portion of thesecond housing 12 and the injection member 16. The injection member 16may be a needle in one embodiment. In another non-limiting embodiment,the injection member 16 may be an injection simulation member. Asimulation or training container may be used in place of the container11 and may be configured to cooperate with the actuation mechanism 38,wherein the injections simulation member is used in place of aninjection member in the training or simulation container. A projectionmember 40 is provided in FIGS. 1A-1B, the projection member 40 can beused to interact with the actuation mechanism 38 as is described in moredetail below. It will be apparent to those skilled in the art, in viewof the teachings herein that, the projection member 40 is an optionalfeature, and are not required for operation of the container 11,depending on the type of actuation implemented.

In FIG. 1B, the second contaminant barrier 34 is embodied as an o-ringtype seal, however, different types of contaminant barriers or seals canbe used. This embodiment is provided for example only, and not in alimiting capacity. FIGS. 2A-2D′ illustrate an embodiment of the deviceand system wherein the actuation mechanism 38 is a rotational member. Inone non-limiting example, the rotational member can be an index cam. Theactuation mechanism 38 includes a first threaded portion 46 and a secondthreaded portion 44, in one embodiment, provided to integrate with andprovide movement of the various components of the container 11 toexecute an injection or a simulated injection. In the Figures provided,the rotatable actuation mechanism 38 includes two threaded portions;however, one skilled in the art would appreciate that the same could beaccomplished with only one threaded portion or with more than twothreaded portions on the rotatable member 38. In the Figures shownherein, the rotational member is associated with a motor 54 provided, inan embodiment, to power or activate the rotational member or actuationmechanism 38.

FIG. 2A provides a top end view of a rotatable actuation mechanism 38and a container 11 in a first position. Once the rotatable actuationmechanism 38 is activated, it is rotated in a first direction such thatthe second threaded portion 44, which interacts with a projection member40 on the first housing 10 of the container 11 is moved in a firstdirection relative to the second housing 12 to bias the spring 30 andextend the injection member 16 through the first contaminant barrier 26as demonstrated in FIGS. 2B and 2B′. As the rotatable actuationmechanism 38 continues its rotation in the first direction, a firstthreaded portion 46 comes in contact with the plunger component 28 andby continued rotation of the rotatable actuation mechanism 38 theplunger component 28 is moved in a first direction relative to the firsthousing 10 to deliver the medicament 14 through the injection member 16and into the skin of a user as seen in FIGS. 2C and 2C′. FIGS. 2C-2Dshow an opening 52 in the second threaded portion 44 whereby theprojection member 40 is released to release the spring 30 such that thefirst housing 10 moves in a second direction relative to the secondhousing 12 so as to retract the injection member 16 into the secondhousing 12. In an embodiment, the unique identification information 48is provided on the container 11, as can be seen in FIGS. 2A-2D′ and theidentification information reader 50 is provided on the actuationmechanism 38 as is shown in FIGS. 2C′-2D′. It should be borne in mindthat all patents, patent applications, patent publications, technicalpublications, scientific publications, and other references referencedherein are hereby incorporated by reference in this application in orderto more fully describe the state of the art to which the presentinvention pertains.

It is important to an understanding of the present invention to notethat all technical and scientific terms used herein, unless definedherein, are intended to have the same meaning as commonly understood byone of ordinary skill in the art. The techniques employed herein arealso those that are known to one of ordinary skill in the art, unlessstated otherwise. For purposes of more clearly facilitating anunderstanding the invention as disclosed and claimed herein, thepreceding definitions are provided.

While a number of embodiments of the present invention have been shownand described herein in the present context, such embodiments areprovided by way of example only, and not of limitation. Numerousvariations, changes and substitutions will occur to those of skill inthe art without materially departing from the invention herein. Forexample, the present invention need not be limited to best modedisclosed herein, since other applications can equally benefit from theteachings of the present invention. Also, in the claims, anymeans-plus-function and step-plus-function clauses are intended to coverthe structures and acts, respectively, described herein as performingthe recited function and not only structural equivalents or actequivalents, but also equivalent structures or equivalent acts,respectively. Accordingly, all such modifications are intended to beincluded within the scope of this invention as defined in the followingclaims, in accordance with relevant law as to their interpretation.

1. A container for storing a medicament prior to use, the containercomprising: a first housing for containing a medicament; a secondhousing, wherein the first housing is movable relative to the secondhousing; and an injection member associated with a lower portion of thefirst housing; wherein when the first housing moves relative to thesecond housing in a first direction to deliver the medicament, theinjection member extends from the second housing traversing a firstcontaminant barrier disposed at a lower portion of the second housing,and when the first housing moves relative to the second housing in asecond direction the injection member is retracted into the secondhousing to prevent an unintentional contact with the injection member.2. The container of claim 1, further comprising a stopper associatedwith the first housing, said stopper being movable relative to the firsthousing, whereby the medicament is delivered through the injectionmember upon movement of the first housing relative to the second housingin a first direction followed by movement of the stopper relative to thefirst housing in a first direction.
 3. The container of claim 2, whereinthe injection member traverses the first contaminant barrier and thestopper is depressed so as to deliver the medicament through theinjection member.
 4. (canceled)
 5. The container of claim 1, wherein aspring is disposed between the first and second housings such that whenthe first housing moves relative to the second housing in a firstdirection, the spring is biased, and after the medicament is deliveredfrom the injection member the spring is released and the injectionmember is retracted into the second housing.
 6. The container of claim1, further comprising a second contaminant barrier between the secondhousing and the first housing to prevent contaminants from entering thesecond housing.
 7. The container of claim 2, wherein the stopper isassociated with a shaft.
 8. The container of claim 2, wherein thestopper is associated with a third contaminant barrier.
 9. The containerof claim 8, wherein the third contaminant barrier prevents contaminantsfrom entering the first housing and/or the medicament.
 10. The containerof claim 1, wherein the container does not comprise an actuationmechanism.
 11. A medicament delivery or injection simulation system,comprising: a container, the container comprising a first housing and asecond housing, wherein the first housing is movable relative to thesecond housing; an injection member or an injection simulation memberassociated with a lower portion of the first housing, wherein when thefirst housing moves relative to the second housing in a first direction,the injection member or injection simulation member extends from thesecond housing traversing a first contaminant barrier disposed at alower portion of the second housing, and the first housing movesrelative to the second housing in a second direction the injectionmember or injection simulation member is retracted into the secondhousing to prevent an unintentional contact with the injection member orinjection simulation member; and an actuation mechanism associated withthe container, wherein said actuation mechanism drives the movement ofthe first housing.
 12. The medicament delivery or injection simulationsystem of claim 11, wherein the actuation mechanism comprises a motor.13. (canceled)
 14. The medicament delivery or injection simulationsystem of claim 11, wherein the container comprises a medicament. 15.The medicament delivery or injection simulation system of claim 11,further comprising a stopper associated with the first housing, saidstopper being movable relative to the first housing, whereby themedicament is delivered through the injection member upon movement ofthe first housing relative to the second housing in a first directionfollowed by movement of the stopper relative to the first housing in afirst direction.
 16. The medicament delivery or injection simulationsystem of claim 15, wherein the actuation mechanism comprises a motorthat drives the movement of the stopper.
 17. The medicament delivery orinjection simulation system of claim 11, further comprising a secondcontaminant barrier between an upper portion of the second housing andthe lower portion of the first housing to prevent contaminants fromentering the second housing.
 18. The medicament delivery or injectionsimulation system of claim 15, wherein a third contaminant barrier isdisposed between the stopper and the first housing to preventcontaminants from entering the first housing and/or the medicament. 19.The medicament delivery or injection simulation system of claim 11,further comprising a reusable housing, said reusable housing comprisinga receptacle for receiving said container.
 20. The medicament deliveryor injection simulation system of claim 19, wherein said actuationmechanism is in said reusable housing.
 21. The medicament delivery orinjection simulation system of claim 15, further comprising a shaftconnected to said stopper.
 22. A container for storing a medicamentprior to use, the container comprising: a first housing for containing amedicament; a second housing, wherein the first housing is movablerelative to the second housing; an injection member associated with alower portion of the first housing; and a plunger associated with thefirst housing, said plunger being movable relative to the first housing;wherein when the first housing moves relative to the second housing in afirst direction to deliver the medicament, the injection member extendsfrom the second housing traversing a first contaminant barrier disposedat a lower portion of the second housing, and wherein when the plungermoves relative to the first housing in a first direction, medicament isdelivered through the injection member, and when the first housing movesrelative to the second housing in a second direction the injectionmember is retracted into the second housing to prevent an unintentionalcontact with the injection member.